PIONEER LOWTOP SPINAL ROD SYSTEM by PIONEER SURGICAL TECHNOLOGY

The Pioneer LowTop Spinal Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Device Description

Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device (Pioneer LowTop Spinal Rod System) and does not describe an AI/ML device or its performance study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them.

The document discusses:

Device name, classification, and intended use.
Predicate devices.
Material specifications.
Performance data: "Testing per recognized ASTM standards was presented."
Substantial equivalence determination based on comparisons to predicate devices.

It does not contain any information about:

Acceptance criteria in the context of an AI/ML device.
Reported device performance of an AI/ML system.
Sample sizes for test sets or data provenance for AI/ML.
Experts for ground truth, adjudication methods, or MRMC studies.
Standalone AI algorithm performance.
Ground truth types for AI/ML.
Training set size or ground truth establishment for a training set.

Summary

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K072187

3.0 Summary of Safety and Effectiveness Information

Sponsor:	Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 226-4812Contact: Jonathan M. Gilbert
	OCT 12 2007
Device Name:	Pioneer LowTop Spinal Rod System
Classification Name:	Spinal Interlaminal Fixation Orthosis, Spinal IntervertebralBody Fixation Orthosis, Spondylolisthesis Spinal FixationDevice System and Pedicle Screw Spinal System, Class II.
Classification, Name,Number & Code:	Regulation Number: 888.3070, Class IIPedicle Screw SystemProduct Code: MNI and MNH
Predicate Device:	K070933 – LowTop Pedicle Screw System (SE Date 6/13/07)K070973 – Quantum Spinal Rod System (SE Date 7/3/07)
Intended Use:	The Pioneer LowTop Spinal Rod System is intended toprovide immobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in thetreatment of the following acute instabilities or deformities ofthe thoracic, lumbar, and sacral spine: degenerativespondylolisthesis with objective evidence of neurologicalimpairment, trauma (i.e., fracture or dislocation), deformitiesor curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinaltumor, and failed previous fusion (pseudoarthrosis).In addition, this device is a pedicle screw system indicated forthe treatment of severe spondylolisthesis (Grade 3 and 4) ofthe L5-S1 vertebra in skeletally mature patients receivingfusion by autogenous bone graft having implants attached tothe lumbar and sacral spine (L3 to S1) with removal of theimplants after the attainment of a solid fusion.
Material:	Materials used to manufacture the implants and instruments ofthis system are in conformance with ASTM StandardSpecifications.
Performance Data:	Testing per recognized ASTM standards was presented.
Performance and SEDetermination:	Comparisons of device performance data, materials,indications and design/function to predicate devices wereprovided in making a determination of substantial equivalence.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pioneer Surgical Technology % Mr. Jonathan M. Gilbert VP of Clinical & Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855

OCT 1 2 2007

Re: K072187

Trade/Device Name: Pioneer LowTop Spinal Rod System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: October 2, 2007 Received: October 4, 2007

Dear Mr. Gilbert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jonathan M. Gilbert

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Darbarc Mchup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0 Indications for Use Statement

K072187 510(k) Number (if known):

Device Name:

Pioneer LowTop Spinal Rod System

Indications for Use:

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deubare Bueher fohrm

al. Restorative. and Neurologica

510(k) Number K07287

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.